Discussion
We expect this study to provide the best scientific evidence for defining better diagnostic strategies for use in detecting caries in primary teeth. Considering the research architecture in diagnosis [
34], the diagnostic studies have basic designs with increasing level of evidence for answering four basic questions in diagnostic research. The first three basic questions are answered through cross-sectional studies for method validation. Studies that address Phase 3 questions are performed to test the method in the target populations selected, consecutively or randomly, reducing the chance of selection bias, which may overestimate the performance of the diagnostic methods [
35]. Several cross-sectional studies of accuracy have been published evaluating different methods of caries detection [
36‐
38]. Nevertheless, we observed that most studies are lacking in the evaluation of clinically relevant aspects or patient-centered outcomes [
39].
We observed in a recent published study that the additional tests do not bring great benefits to detect carious lesions in primary molars [
12]. Since the introduction of selection bias was minimized in this study, strong evidence exists with respect to the detection of caries in primary teeth.
However, randomized clinical trials evaluating relevant outcomes for patients (Phase 4 questions) represent a higher degree of evidence in diagnostic research. This type of study is conducted to evaluate if patients who undergo a diagnostic method fare better than untested patients [
34]. As an example, we can cite the issue of mammography for breast cancer detection. The validity of mammography has been confirmed by cross-sectional studies that perform the biopsy as the gold standard [
40]. However, it is known that the real benefit of performing mammography as a screening test in women between 40 and 50 years of age is small. This observation is because the test would prevent death from breast cancer in less than 0.01 % of women under age 50 who undergo screening. Considering the problems of unnecessary treatment due to false-positive results, stress caused by the diagnosis of women who do not die from this disease (correct and incorrect diagnoses) and other problems, the risks outweigh the benefits of mammography in this age group [
41]. This type of results can be only evaluated in randomized clinical trials because the validity studies do not deal with this aspect.
Until now, however, no randomized clinical trial was conducted to evaluate caries diagnosis strategies. With the expected results, we aim to achieve the refutation of the recommendation to conduct bitewing radiographs for detecting caries lesions, even in children without signs or symptoms, which is present in all protocols of clinical procedures worldwide. On the other hand, in case of favorable results obtained with the experimental group, we will confirm the benefits of strategies of caries detection advised by those clinical guidelines. To the best of our knowledge, this is the first randomized clinical trial to evaluate diagnostic strategies for diseases related to the oral cavity, considering the whole playing field of dentistry.
Competing interests
The author(s) declare that they have no competing interests.
Authors’ contributions
FMM, DPR, MMB, CMP, and EMC contributed to the conception of this trial. FMM was responsible for its design. TFN is the trial coordinator, and FMM is the principal investigator. FMM and TG drafted the protocol. LRAP and TG are in charge of participants’ recruitment. TFN and JSL are examiners and responsible for treatment plans. LCB and DPR are responsible for organizing and monitoring dental treatments. All authors critically reviewed and approved the final manuscript as submitted. The CARDEC collaborative group staff members are responsible for promoting, organizing and conducting all procedures related to the study. Members are graphic designers and secretaries, who disseminate information and organized the clinical, and dentists and assistants who perform dental treatment and orientations for all study participants.
*CARDEC collaborative group
Alessandra Reyes, Ana Estela Haddad, Ana Flavia Bissoto Calvo, Ana Lidia Ciamponi, Andrezza Stewien Fonseca, Annelry Costa Serra, Antonio Carlos Lopes Silva, Beatriz de Albuquerque Bispo, Bruna de Paula Okamura, Bruna Lorena Pereira Moro, Carmela Rampazzo Bresolin, Carolina de Picoli Acosta, Caroline Moraes Moriyama, Claudio Mendes Pannuti, Daniela Pereira de Souza, Daniela Prócida Raggio, Danilo Antonio Duarte, Edgard Michel-Crosato, Eduardo Kazuo Kohara, Fausto Medeiros Mendes, Gislaine Aparecida Almeida Dias, Haline Cunha Medeiros Maia, Isaac Murisi Pedroza Uribe, Isabel Cristina Olegário da Costa, Isabela Floriano Martins, José Carlos P. Imparato, Juan Sebastian Lara, Judith Liberman Perlmuter, Julia Gomes Freitas, Júlia Maria Ribeiro Fonseca, Kianne Santos Chaves, Laura Regina Antunes Pontes, Laysa Yoshioka, Leticia Tiemi Hashizume, Ligia Akemi, Lucas Botelho Gazzinelli, Lucila Basto Camargo, Marcelo Bonecker, Marcia Turolla Wanderley, Maria Salete Nahás Pires Corrêa, Mariana Minatel Braga, Michele Baffi Diniz, Pamela Rocha Lopes de Almeida, Renata Marques Samuel, Renata Saraiva Guedes, Sergio Marcelino Covos, Simone Cesar, Tamara Kerber Tedesco, Tatiane Fernandes Novaes, Thais Gimenez and Thiago Machado Ardenghi.